S2206, Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III BreS2206, Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III BreThis clinical trial aims to validate the results observed in I-SPY2 and will test if adding durvalumab to neoadjuvant chemotherapy can increase pCR rates, shift residual cancer burden to lower values and improve invasive breast cancer free survival in early-stage HRpositive MP2 cancers.ClinicalTrials.gov registration not requiredKate Lathrop M.D.

Phase 1 Clinical Trial of Avasopasem in Patients with Metastatic Hormone Receptor Positive Breast Cancer with Progression on a CDK 4/6 Inhibitor and Hormonal TherapyPhase 1 Clinical Trial of Avasopasem in Patients with Metastatic Hormone Receptor Positive Breast Cancer with Progression on a CDK 4/6 Inhibitor and Hormonal TherapyThis is a single institution, non-randomized, phase 1 with a dose expansion clinical trial investigating the addition of a novel agent, Avasopasem (GC4419), in patients with hormonal receptor positive (HR+) metastatic breast cancer with progression while on treatment with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and an aromatase inhibitor.ClinicalTrials.gov registration not requiredKate Lathrop M.D.

APOBEC3 Expression in HPV-Related Malignancies as a Novel Biomarker of Response to Definitive ChemoradiationAPOBEC3 Expression in HPV-Related Malignancies as a Novel Biomarker of Response to Definitive ChemoradiationThis is a non-randomized biomarker study with the aim to evaluate the relationship between APOBEC3B (A3B) expression in primary head and neck cancers (HNC), anus, and cervix tumors and pathologic response to definitive chemoradiation therapy.ClinicalTrials.gov registration not requiredShraddha Dalwadi, MD, MBA

NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger).ClinicalTrials.gov registration not requiredShraddha Dalwadi, MD, MBA

Shortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-Center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men with Node-Positive and High-Risk Node-Negative InvShortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-Center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men with Node-Positive and High-Risk Node-Negative InvTo learn about the effects of shorter RNI regimens in patients with breast cancer who have had a lumpectomy or mastectomy and who are at higher risk for lower risk for the disease returning.NCT07076485Shraddha Dalwadi, MD, MBA

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of
Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of
Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous This is a Phase 2, randomized, active-controlled, parallel-group, multisite, open-label studyof belzutifan plus fulvestrant versus everolimus plus ETPC (fulvestrant or exemestane) inparticipants with ER+/HER2- unresectable, locally advanced, or mBC.ClinicalTrials.gov registration not requiredSaba Shaikh, MD

MK-5684-015: A Multicenter, Open-label, Phase 2 Basket Study of
MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)MK-5684-015: A Multicenter, Open-label, Phase 2 Basket Study of
MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)MK-5684 is being developed for treatment of solid tumors. This basket study of MK-5684 isdesigned to assess the safety, tolerability, and preliminary efficacy of MK-5684 in selectedadvanced solid tumor indications.ClinicalTrials.gov registration not requiredSaba Shaikh, MD

A Phase 2, Randomized, Multicenter, Open-Label Neoadjuvant Study Evaluating Zanidatamab in Combination with Chemotherapy in Participants with HER2-Positive Breast Cancer A Phase 2, Randomized, Multicenter, Open-Label Neoadjuvant Study Evaluating Zanidatamab in Combination with Chemotherapy in Participants with HER2-Positive Breast Cancer The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer.NCT07102381Saba Shaikh, MD